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Book Training Unit 6

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Chapter 7 The Software Supplier’s Role in Computer Validation, Appendix 7.1-7.4

 

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Chapter 7 The Software Supplier’s Role in Computer Validation, Appendix 7.1-7.4

This unit discusses styles of software development with an emphasis on an iterative design methodology that produces software development life cycle (SDLC) evidence that can pass audits and inspections. It looks at the software architecture document (SAD) and CASE tool management from a compliance and audit perspective. Unit 6 presents the supplier’s software verification version of the auditable package model first discussed in Unit 3. The appendices give examples of an SDLC SOP, a Milestone Definition SOP, and OQ Verification Plan and Test Plan.

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